The Recall Desk

Hazard

Device Separation recalls

89 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
89
Critical
9
Severe
50
Most recent
2026-05-13

Of the 89 device separation recalls we have scored against our rubric, 9 (10%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 50 (56%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all device separation recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

76–89 of 89

  • HighFDA (Devices)·Z-2243-2014·2014-09-03

    Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation

    Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.

    Product
    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign object
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1981-2014·2014-07-09

    Vascular Solutions Recalls Langston Dual Lumen Catheters Due to Separation Risk

    Vascular Solutions is recalling Langston Dual Lumen Catheters because the inner catheter may separate from the hub during use, potentially requiring intervention to prevent injury.

    Product
    Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0440-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 274 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 28 cm Ureteral Access Sheath Set Product No M0062502270, RDF Catalog No 250-227, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0442-2014·2013-12-11

    Boston Scientific Recalls Navigator HD Ureteral Access Sheath Sets

    Boston Scientific is recalling 449 units of Navigator HD Ureteral Access Sheath Sets because the dilator tip may separate from the body.

    Product
    Navigator HD l3F/15F x 46cm Ureteral Access Sheath Set Product No M0062502280, RDF Catalog M0062502290, Sterile. Indicated for use in endoscopic procedures to facilitate the passage of endoscopes, urological instruments and for the injection of fluids into the urinary tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1524-2013·2013-06-19

    Bard UltraClip breast tissue marker recall due to separation risk

    Bard Peripheral Vascular is recalling UltraClip breast tissue markers because the metal marker may separate from the needle before use.

    Product
    BARD Biopsy Systems UltraClip Dual Trigger breast tissue marker. Intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1542-2013·2013-06-19

    Edwards Recalls QuickDraw Venous Cannula Due to Separation Complaints

    Edwards Lifesciences is recalling QuickDraw Venous Cannulas because the device may separate during withdrawal when using the percutaneous insertion method.

    Product
    QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) go into one shelf carton. One shelf carton goes in one ship
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1275-2013·2013-05-22

    Cook Medical Recalls Zilver PTX Drug-Eluting Peripheral Stent

    Cook Medical is recalling Zilver PTX Drug-Eluting Peripheral Stents due to delivery system fractures and tip separations that resulted in one death.

    Product
    Zilver PTX Drug-Eluting Peripheral Stent, - 7 mm X 80mm; 125 cm, Rx, Sterile Product Usage: The Zilver PTX Drug -Eluting Peripheral Stent is a self expanding, small metal, mesh tube (stent) with the outer surface coated with the drug Paclitaxel that can be Implanted in an art
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0706-2013·2013-01-30

    DePuy Spine Recalls VIPER Polyaxial Screws Due to Potential Separation

    DePuy Spine is recalling 36 units of VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0709-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

    DePuy Spine is recalling VIPER Polyaxial Screws 8x80mm and larger because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0710-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

    DePuy Spine is recalling VIPER polyaxial screws because the shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0707-2013·2013-01-30

    DePuy Spine VIPER Polyaxial Screws Recalled for Potential Separation

    DePuy Spine is recalling VIPER Polyaxial Screws because the screw shank may separate from the head during high-torque insertion.

    Product
    DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2013·2012-12-12

    OmniGuide BP-ROBOTIC Fiber Recalled Due to Glue Joint Failure

    OmniGuide, Inc. is recalling 45 units of BP-ROBOTIC single-use fibers because a glue joint failure may cause the device to shift and fall into the patient.

    Product
    OmniGuide BP-ROBOTIC ( BeamPath Robotic), Single Use Cat. # BP-ROBOTIC The OmniGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0067-2013·2012-10-24

    ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.

    Product
    "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-0068-2013·2012-10-24

    ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Tip Separation Risk

    ConMed Linvatec is recalling PressFT HI-FI Sutures because the distal tip of the driver may separate from the shaft after the implant is inserted.

    Product
    NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
    Category
    Medical Device
    Distribution
    17 states